USP <800>: Have You Made the Transition?

It’s finally here (well, technically it just passed)–December 1, 2019– a.k.a the deadline for all USP <800> regulations and procedures to be in place. 

And one thing you can be sure of…is that inspections are imminent. 

But if you’re still a little fuzzy on what you should know about USP <800>, we’ve broken down some of the information for you. 


First and foremost: What is USP <800>?

The United States Pharmacopeia (USP) General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment.  

In the past, a facility had to pull together multiple sources and references (from many different acronyms)—including OSHA [the Occupational Safety and Health Administration], NIOSH [the National Institute for Occupational Safety and Health], ASHP [the American Society of Health-System Pharmacists], and ONS [the Oncology Nursing Society]—to develop a recommendation for the handling and disposal of hazardous drugs. 

So, to say having this one source of truth and reference is ideal is an understatement.   

What is considered a hazardous drug?

The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.

(A list of HD’s can be found here.)

Who is affected by USP <800>?

According to the Centers for Disease Control and Prevention (CDC), over 8 million healthcare personnel in the United States are exposed to hazardous drugs each year. 

Although hazardous drugs (HD’s) may be pharmaceuticals, USP <800> is not solely a pharmaceutical regulation or concern.  

Virtually all types of practices—from community health centers and ambulatory surgery centers, to skilled nursing facilities and hospitals—will have to meet the new compliance standards.  

USP <800> applies to all healthcare personnel who handle HD preparations including pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. 

USP <800> also applies to all facilities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals, and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices).

Both clinical and nonclinical healthcare workers, as well as patients in any setting where hazardous drugs are handled, may be at risk of hazardous drug exposure and contamination during the life cycle of hazardous drugs—from shipping and receiving, transport and distribution, compounding, administration, and waste disposal. 

When does HD contamination occur?

One misconception about HD’s is that they only affect those directly administering or receiving these drugs. 

However, several studies support that contamination also occurs in personnel who are not responsible for compounding or administering hazardous drugs. 

Non-clinical hospital staff who may be exposed to hazardous drugs include shipping and receiving personnel, environmental services workers (eg, housekeeping, laundry, and maintenance), and workers involved in the transport or disposal of hazardous drugs or waste. 

Patients, caregivers and family members of patients or visitors and secondary contacts of patients are also at increased risk of unintentional hazardous drug exposure.

This can be through contact with contaminated surfaces in health care settings or items contaminated with the excreta (eg, urine, stool, and sweat) of patients who received hazardous drugs.

What are some of the most vulnerable places for HD contamination/exposure?

Measurable levels of contamination with hazardous drugs have been reported in-patient care areas, including floors, tables, and chairs, and other areas throughout the hospital, which unduly increase the risk of exposure through skin contact. 

In addition to patients treated in the healthcare setting, family members and other visitors may also be exposed to hazardous drugs through contact with any contaminated surfaces. 

The urine, stool, and sweat of patients treated with certain hazardous drugs may contain varying amounts of these agents, which creates a potential route of exposure for caretakers, family, and friends of patients as well.

This means that once those exposed to these drugs leave the healthcare setting and go into their private residences…caution should still be employed and proper sanitation of surfaces is a priority.  

How do you implement changes into your facility? 

One major challenge for medical practices is that the whole premise for pharmacy standards assumes an operations model where the mixing process uses dedicated staff, whereas in medical practice, mixing is usually conducted by multifunctional staff (often nurses) who have other responsibilities pertaining to patient care and treatment administration.

Here are a few steps that facilities can take to prepare and navigate the complexities of USP 800 compliance: 

  • appoint a designated compliance leader 
  • perform an assessment of risk
  • determine hazardous drugs used at your facility/practice
  • develop standard operating procedures specific to your practice/facility 
  • focus on education/training